DUBLIN--(BUSINESS WIRE)--The "Viral Clearance and Viral Testing Services Market - Distribution by Scale of Operation, Method of Viral Clearance and Testing, End-User and Key Geographical Regions: Industry Trends and Global Forecasts, 2023-2035" report has been added to ResearchAndMarkets.com's offering.
Viral clearance and viral testing refers to the detection and elimination of viral contaminants, using a wide array of methods, to ensure the product's safety for human use. Over the past few years, viral clearance and viral testing has emerged as one of the key pre-requisites for biopharmaceutical regulatory approvals. It is worth mentioning that, till date, over 630 biologics have already been approved by the Food and Drug Administration (FDA), while more than 8,000 biopharmaceuticals are in the clinical evaluation process. This increased number of approvals and ongoing clinical trials in the biopharmaceutical industry has resulted in a rise in the demand for such studies.
Benefits and Growing Demand for Viral Clearance and Viral Testing Services
Viral clearance and testing studies have emerged as a mandatory step for regulatory submissions of biologics for commercial applications. These studies result in streamlined manufacturing of contamination free / safe products and on-time delivery of biologics. Owing to this, the demand for these services has increased significantly. It is worth highlighting that, with the continuous revision of the regulatory guidelines, viral clearance and testing studies are already amongst the most essential steps in the manufacturing of biologics, including antibodies, blood products, cell and gene therapies, hormones, recombinant proteins, therapeutic proteins and vaccines.
Need for Outsourcing Viral Clearance and Viral Testing Studies
The rise of biologics has resulted in an increasing demand for viral clearance and testing studies. However, these studies are quite cost intensive, time-consuming and follow stringent regulatory guidelines. In addition, they require specialized technical skills and good scientific expertise. This has prompted the biopharmaceutical developers to outsource these studies to the service providers, which have aseptic laboratories, GMP-certified facilities and specialized equipment in accordance with the requirements of regulatory authorities.
Current Market Landscape of Viral Clearance and Testing Service Providers
The viral clearance and viral testing service providers landscape features a mix of large, mid-sized and small companies, which have the required expertise to offer various services for the viral clearance and testing of biologics, across the manufacturing and purification stages. It is worth highlighting that majority of the service providers are large companies. Recent developments in this segment of the biopharmaceutical industry indicate that the service providers are upgrading their capabilities and infrastructure to accommodate the current and anticipated demand for these services.
Key Drivers in the Viral Clearance and Viral Testing Services Market
Since the onset of the COVID-19 pandemic, viral clearance and viral testing services for biopharmaceuticals have garnered significant attention. In addition, the success of next-generation sequencing in efficiently detecting a wide variety of viruses has created an enormous need for the consistent usage of such advanced tools / methods in viral clearance and testing studies. In the coming decade, several promising techniques, specifically those exhibiting enhanced efficacy, are anticipated to develop at a faster rate.
Moreover, considering the active involvement of large players as well as the new entrants, the viral clearance and testing services market is likely to witness healthy growth. Further, to address the growing demand for these services, various large players have undertaken several initiatives, including strengthening their respective service portfolios, entering into strategic deals, and expanding their facility and capacity.
Market Size of the Viral Clearance and Viral Testing Services Market
Driven by the rising interest in research and development activities and the demand for viral clearance and testing services, the future opportunities and growth associated with this market are anticipated to witness a noteworthy growth in the foreseen future. Specifically, in terms of end-users, the market is anticipated to be driven by biotechnology and pharmaceutical industry. In addition, presently, more than 60% of the market is captured by players based in North America and Europe.
Key Players in the Viral Clearance and Viral Testing Services Market
Examples of key players engaged in this domain (which have also been captured in this report) include Charles River Laboratories, Creative Biolabs, Eurofins Scientific, Microbac Laboratories, MilliporeSigma, Nelson Labs, Syngene International, Texcell, Vironova and WuXi Biologics.
Scope of the Report
The study presents an in-depth analysis of the various firms / organizations that are engaged in this domain, across different segments.
Amongst other elements, the report includes:
- An executive summary of the insights captured during our research. It offers a high-level view on the current state of viral clearance and testing services market and its likely evolution in the mid-long term.
- A general overview of the viral clearance and testing studies, highlighting details on viral contamination in biologics and the need for viral clearance and testing. It also presents information on the process of viral clearance and testing, and regulatory guidelines related to viral contamination. Additionally, it features a discussion on the future perspectives of the viral clearance and testing industry.
- A detailed assessment of the overall market landscape of the companies offering viral clearance and testing services, based on several relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, location of viral clearance and testing facilities, type of virus detected (by envelope - RNA enveloped, RNA non-enveloped, DNA enveloped and DNA non-enveloped), type of virus detected (by class - retrovirus, adenovirus, lentivirus, adeno-associated virus (AAV), herpesvirus and others), key offerings (viral clearance services, viral testing services and viral clearance products), type of biologic(s) analyzed (antibodies, cell and gene therapies, vaccines, recombinant proteins, blood and blood products, hormones and others), method(s) of viral clearance (inactivation - pH treatment, solvent detergent, heat pasteurization and others), method(s) of viral clearance (removal - chromatography, filtration, precipitation and others) and type of viral testing service(s) offered (cell bank testing, raw material testing, unprocessed bulk testing and end of production process testing).
- A detailed competitiveness analysis of viral clearance and testing service providers based in North America, Europe and Asia-Pacific. The analysis compares the service providers based on supplier strength (in terms of years of experience and company size) and service strength (considering key offerings, type of virus detected (by envelope), type of virus detected (by class), method(s) of viral clearance (removal), method(s) of viral clearance (inactivation), viral testing service(s) offered, type of biologic(s) analyzed and additional services offered).
- Tabulated profiles of key players based in North America, Europe and Asia-Pacific that are engaged in providing services related to viral clearance and testing (shortlisted based on strength of service portfolio). Each profile includes a brief overview of the company, financial information (if available), information on viral clearance and testing related services, recent developments and an informed future outlook.
- An in-depth analysis of various patents that have been filed / granted for viral clearance and testing, since 2017, based on various relevant parameters, such type of patent, publication year, application year, type of organization, emerging focus areas, geographical location, CPC symbols, leading players (in terms of number of patents granted / filed), patent benchmarking (in terms of CPC symbols and leading players), patent characteristics and patent age. It also includes an insightful patent valuation analysis and list of leading patents by number of citations.
Frequently Asked Questions
Question 1: What is viral contamination in biopharmaceutical industry?
Answer: Viral contamination is a serious threat to the biopharmaceutical industry; it occurs when the biologics are infected by the endogenous and adventitious viruses, during the production process. The potential sources of these viruses include cell lines, blood, hormones and other animal or human derived unprocessed material.
Question 2: How many players are providing services related to viral clearance and viral testing?
Answer: Presently, more than 30 companies offer various services related to viral clearance and testing, including viral testing services (such as cell bank testing, raw material testing, unprocessed bulk testing and end of production process testing) and viral clearance services (such as several virus inactivation and removal methods). In addition, few service providers offer services for the specialized detection and removal of prions and transmissible spongiform encephalopathies (TSE).
Question 3: How many patents, related to viral clearance and viral testing, have been filed / granted in the last few years?
Answer: More than 260 patents, related to viral clearance and viral testing, have been filed / granted in the last few years. It is worth mentioning that most of the patents have been filed by industry players and are focused on viral removal methods and techniques.
Question 4: What is the partnership and collaboration trend in viral clearance and viral testing services domain?
Answer: Currently, mergers and acquisitions are the most preferred type of partnership models adopted by the stakeholders in this domain. This is followed by service agreements, service alliances and technology assessment agreements.
Question 5: Which segment is likely to have the largest share in the viral clearance and viral testing services market?
Answer: Presently, viral removal dominates the viral clearance and testing services market. This can be attributed to the ongoing innovations and advancements in viral removal techniques, such as chromatography, filtration, and precipitation.
Question 6: What are the recent developments in the viral clearance and viral testing services market?
Answer: Viral clearance and testing service providers have made significant investments to expand their respective capabilities through the incorporation of advanced methods, technologies, and platforms; this is required for attracting a client base across different geographies. In addition, players have also inked a number of partnerships to enhance their expertise, technology and operations portfolio.
Question 7: Which geographical segment has the highest growth rate in viral clearance and viral testing services market?
Answer: Europe is likely to grow at the highest CAGR, during the period 2023- 2035.
A Selection of Companies Mentioned
- 3P Biopharmaceuticals
- Advantar Laboratories (acquired by Eurofins Scientific)
- Advinus Therapeutics (acquired by Eurofins Scientific)
- ICAR-Agricultural Technology Research Institute (ATRI)
- ams Laboratories (acquired by Eurofins Scientific)
- Analytical Lab Group (ALG) (acquired by Element Materials Technology)
- Asahi Kasei Medical
- Astellas Pharma
- Avance Biosciences
- Avomeen (acquired by Element Materials Technology)
- Baxalta (acquired by Takeda Pharmaceutical)
- BioOutsource (acquired by Sartorius Stedim Biotech)
- BioScience Laboratories (acquired by Nelson Labs)
- BSL BIOSERVICE (acquired by Eurofins Scientific)
- Creative Biogene
- Charles River Laboratories
- Clean Cells
- Creative Biolabs
- Cygnus Technologies (acquired by Maravai LifeSciences)
- EAG Laboratories (acquired by Eurofins Scientific)
- Element Materials Technology (Element)
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